Acoma Medical Imaging, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Acoma Medical Imaging, Inc.” (first 1989, latest 1998), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | 2 | 2 |
| IZL | System, X-Ray, Mobile | 2 | 2 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 2 | 2 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| KPX | Changer, Radiographic Film/Cassette | 1 | 1 |
Review panels
- Radiology (13)
Most recent Acoma Medical Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981227 | SYMPHONY 360 REMOTE CONTROL TABLE | JAA | 1998-06-30 | 88 |
| K981131 | PATHFINDER MOBILE C ARM | OXO | 1998-06-26 | 88 |
| K963851 | TILTING RADIOGRAPHIC TABLE (REMOTE) | IXR | 1997-01-23 | 120 |
| K944952 | ANGIOGRAPHIC SYSTEM | IZI | 1995-02-17 | 133 |
| K941017 | F/C/W TUBESTAND | IYB | 1994-07-29 | 148 |
| K941004 | CTS SYSTEM | IYB | 1994-07-29 | 150 |
| K925598 | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER | KPX | 1993-02-01 | 88 |
| K921116 | PX-100 PORTABLE X-RAY GENERATOR | IZL | 1992-10-05 | 210 |
| K921425 | SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R | IZL | 1992-08-27 | 156 |
| K902637 | FUTURUS 2001 X-RAY GENERATOR | IZO | 1990-08-03 | 50 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acoma Medical Imaging, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Acoma Medical Imaging, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Acoma Medical Imaging, Inc.” (first 1989, latest 1998), across 10 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acoma Medical Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acoma Medical Imaging, Inc. is 120 days.
Which FDA product codes appear under Acoma Medical Imaging, Inc.?
The most frequent FDA product codes under this applicant name are IYB (Tube Mount, X-Ray, Diagnostic, 2); IZL (System, X-Ray, Mobile, 2); OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile, 2).
Next steps
- See all 13 Acoma Medical Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYB, Acoma Medical Imaging, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.